# K092111: Entomed Screening Audiometer, Model  SA201,SA202, Entomed Diagnostic Audiometer Model SA203,SA204

- Pathway: 510(k) (Traditional)
- Applicant: Entomed AB
- Decided: Oct 2, 2009 after 80 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Interacoustic Diagnostic Audiometer AD229b: named in the summary without a submission number
- (no number) GSI 61 Clinical Audiometer: named in the summary without a submission number

## Indications for use
The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss. The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to be able to understand the basic principles of the test method when explained by the operator.

Source page: https://510kreport.com/device/K092111
Methodology: https://510kreport.com/methodology